Regulatory Affairs Associate - Agricultural Biologicals and Microbial Products

Overview

Our client, an expanding agri-biotech firm focused on sustainable fertilizer innovations, is actively seeking a Regulatory Affairs Associate. This role is suited for professionals with 1-2 years of regulatory experience and academic credentials in Microbiology, Biotechnology, Biology, Medical Sciences, or related areas. The successful candidate will facilitate the registration, renewal, and compliance upkeep of microbial and biological products across multiple international jurisdictions. Collaboration with regulatory bodies, external consultants, laboratories, production, and internal scientific and commercial teams forms a major part of the position.

This position is ideal for an early-stage regulatory specialist passionate about agricultural biologicals including biostimulants, biofertilizers, soil amendments, and biocontrol agents. It is an associate-level role intended for candidates capable of managing submissions independently while receiving guidance from leadership and external regulators.

Key Responsibilities

• Oversee regulatory projects involving new product registrations in countries including the US, Canada, Europe, and the UK.
• Liaise directly with government agencies at federal, state, provincial, and international levels.
• Prepare, submit, and maintain applications for product registrations, amendments, renewals, and required reports.
• Monitor timelines, respond to regulatory queries, and track the status of applications and compliance obligations.
• Develop comprehensive technical dossiers compiling formulations, manufacturing details, safety documentation, efficacy data, microbial identification, and scientific literature.
• Verify accuracy and compliance of technical documents and coordinate with relevant internal teams to source information.
• Maintain orderly and confidential regulatory records regionally and per product.
• Identify regulatory pathways with consultants for product market entry; assess registration requirements and regulations for biological agricultural inputs.
• Support ongoing compliance of product registrations, labels, claims, packaging, and documentation.
• Manage recurring tasks such as renewal deadlines, reporting obligations, fees, and regulatory calendars.
• Review marketing and labeling materials for regulatory adherence prior to product launch.
• Coordinate actions with external consultants, labs, distributors, and government bodies.
• Provide project updates highlighting risks, deadlines, and information gaps.
• Assist in responding to customer regulatory requests and participate in relevant meetings.

Candidate Profile

• Bachelor's degree in Microbiology, Biotechnology, Biology, Agricultural or Life Sciences.
• About 1 to 2 years of experience in regulatory affairs, product registrations, or related technical functions.
• Preferred experience with agricultural inputs such as biological products, fertilizers, biostimulants, or microbial products.
• Familiarity with regulatory dossiers, product labeling, safety data sheets, and certificates of analysis.
• Excellent technical writing, organization, and research skills.
• Ability to manage multiple jurisdictions and deadlines simultaneously with strong confidentiality.
• Effective written and verbal communication.
• Proficiency in Microsoft Office, document management systems, and online regulatory portals.
• Additional advantages include knowledge of US state fertilizer or microbial registrations, Canadian and EU regulations, microbial strain documentation, organic certifications, label review, and experience working with regulatory consultants or agencies.

Core Competencies

• Project coordination and diligent follow-up.
• Scientific and regulatory research aptitude.
• Thorough technical document preparation.
• Attention to detail and compliance management.
• Meeting deadlines and managing regulatory calendars.
• Professional interpersonal communication.
• Interpreting regulations and actionable implementation.
• Enthusiasm for learning diverse international regulatory frameworks.

Benefits

• Engage with innovative biological solutions in a rapidly growing industry.
• Join a dynamic biotech startup offering growth and advancement.
• Access continuous training in microbial and biological agricultural inputs.

Company Commitment

The employer actively opposes racism and discrimination and supports diversity, equity, and inclusion initiatives. They collaborate with organizations fostering success and respect for diverse candidate backgrounds, making inclusivity a core principle in their operations and recruitment.